Business Analyst
1 week ago
ROLES & RESPONSIBILITIES:
- Collaborate with cross-functional teams, including product managers, systems engineers, software engineers and UX designer teams, to gather and document software requirements.
- Ensure traceability of requirements throughout the software development lifecycle, linking them to design, implementation, and testing phases.
- Ensure all software requirements comply with relevant regulatory standards, including IEC-62304.
- Translate business and regulatory needs into detailed functional and non-functional requirements for software development.
- Work closely with the software development team to ensure requirements are understood, feasible, and implemented correctly.
- Participate in risk management activities, including hazard analysis and risk assessment, to ensure the safety and efficacy of the software.
- Support the development of technical documentation required for regulatory submissions and audits.
- Stay up-to-date with the latest regulatory standards and industry best practices related to software as a medical device.
- Bachelor's degree in Computer Science, Engineering, or a related field; advanced degree preferred.
- Minimum of 7+ years of experience in a business analysis role, preferably within the medical device industry.
- Excellent communication skills, both written and verbal, with the ability to interact effectively with technical and non-technical stakeholders.
- Experience with tools such as ADO, JIRA, JAMA or similar for requirements management and traceability.
- Familiarity with software development processes, particularly within an Agile framework.
- Excellent analytical, problem-solving, and communication skills.
- Ability to work collaboratively with cross-functional teams and manage multiple priorities.
- Strong knowledge of IEC-62304, FDA guidelines, ISO 14971, and other relevant standards for medical device software development is a plus.
- Certification in business analysis (e.g., CBAP, PMI-PBA) is a plus.
- Understanding of cybersecurity principles and data privacy regulations (e.g., HIPAA, GDPR) related to medical devices is a plus.
- Previous hands-on software development experience is a plus.
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